cell therapy for cd7 positive acute myeloid leukemia or mixed lineage leukemia

Conditions: Leukemia, T Cell

Summary: this is an open, single-arm, clinical study to evaluate efficacy and safety of anti cd7 car-t cell in the treatment of cd7 positive acute leukemia or mixed lineage leukemia except those who are diagnosed with t-all/t-lbl

the cars consist of an anti-cd7 vhhs, a portion of the human cd137（4-1bb） molecule, and the intracellular component of the human cd3ζ molecule. prior to car-t cell infusion, the patients will be subjected to preconditioning treatment. after car-t cell infusion, the patients will be evaluated for adverse reactions and efficacy. the main research objectives: to evaluate the safety and efficacy of cd7 car-t cells in patients with cd7 positive acute leukemia or mixed lineage leukemia except those who are diagnosed with t-all/t-lbl the secondary research objectives: to investigate the cytokinetic characteristics of cd7 car-t cells in patients with cd7 positive acute leukemia or mixed lineage leukemia except those who are diagnosed with t-all/t-lbl

Eligibility criteria:
inclusion criteria: 1. diagnosis of refractory or relapsed cd7+ acute myeloid leukemia or mixed lineage leukemia was made according to the nccn 2019.v2 guideline. refractory aml is defined as a patient who has failed to achieve complete remission after induction therapy. relapsed aml is defined as the reappearance of blasts (5%) in either peripheral blood or bone marrow. patient diagnosed with aml should be treated and whose disease failed with at least 2 prior lines of therapies. patients whose tumor burden ≥5% blasts, or who have persistent positive minimal residual disease (mrd), or have reappearance of extramedullary lesions are also considered eligible; 2. cd7+ expression on tumor cells (cd7 positive blasts ≥50% by flow cytometry); 3. life expectancy greater than 12 weeks; 4. kps or lansky score≥60; 5. hgb≥70g/l (can be transfused); 6. oxygen saturation of blood\>90%; 7. total bilirubin (tbil)≤3 × upper limit normal, aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 5×upper limit of normal; 8. informed consent explained to, understood by and signed by patient/guardian exclusion criteria: 1. any of the following cardiac criteria: atrial fibrillation/flutter; myocardial infarction within the last 12 months; prolonged qt syndrome or secondary prolonged qt, per investigator discretion. cardiac echocardiography with lvsf (left ventricular shortening fraction)\<30% or lvef(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. cardiac dysfunction nyha(new york heart association) iii or iv (confirmation of absence of these conditions on echocardiogram within 12 months of treatment); 2. has an active gvhd; 3. has a history of severe pulmonary function damaging; 4. with other tumors which is/are in advanced malignant and has/have systemic metastasis; 5. severe or persistent infection that cannot be effectively controlled； 6. merging severe autoimmune diseases or immunodeficiency disease; 7. patients with active hepatitis b or hepatitis c(\[hbvdna+\]or \[hcvrna+\]); 8. patients with hiv infection or syphilis infection; 9. has a history of serious allergies on biological products (including antibiotics); 10. clinically significant viral infection or uncontrolled viral reactivation of ebv(epstein-barr virus), cmv(cytomegalovirus), adv(adenovirus), bk-virus, or hhv(human herpesvirus)-6; 11. presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.; 12. have received transplant treatment for less than 6 months in prior to enrollment; 13. being pregnant and lactating or having pregnancy within 12 months; 14. any situations that the researchers believe will increase the risks for the subject or affect the results of the study